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Clinical trials for NS5B inhibitors

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44345   clinical trials with a EudraCT protocol, of which   7373   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    3 result(s) found for: NS5B inhibitors. Displaying page 1 of 1.
    EudraCT Number: 2013-002458-66 Sponsor Protocol Number: AI443-113 Start Date*: 2013-12-13
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: A Phase 3 Evaluation of a daclatasvir/asunaprevir/BMS-791325 Fixed Dose Combination in Subjects with Genotype 1 Chronic Hepatitis C and Compensated Cirrhosis
    Medical condition: HEPATITIS C VIRUS
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004848 10072848 Hepatitis C virus genotype 1 positive LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: View results
    EudraCT Number: 2014-001739-35 Sponsor Protocol Number: SOFT-preOLT Start Date*: 2014-08-25
    Sponsor Name:Università di Modena e ReggioEmilia
    Full Title: An Open-Label Study to Explore the Clinical Efficacy of Sofosbuvir With Ribavirin Administered Pre-Transplant in Preventing Hepatitis C Virus (HCV) Recurrence Post-Transplant in HIV-HCV infected pa...
    Medical condition: Individuals with HIV-HCV co-infection and end-stage liver disease, with an indication for liver transplantation
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004862 10057212 Hepatitis viral infections HLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2017-003338-94 Sponsor Protocol Number: AI444-423 Start Date*: 2018-05-09
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: Open-Label, Single-Arm Trial to Evaluate the Pharmacokinetics, Safety and Efficacy of Daclatasvir (DCV) in Combination with Sofosbuvir (SOF) in Children from 3 to less than 18 Years of Age with GT-...
    Medical condition: Chronic Hepatitis C (CHC) Infection
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021881 - Infections and infestations 10008912 Chronic hepatitis C PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) ES (Completed) PL (Completed) Outside EU/EEA
    Trial results: View results
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    Query did not match any studies.
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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